NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance for submission dates on or after February 25, 2006 must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 (R&R) forms and the Grants.gov Application Guide SF424 (R&R).APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and should be started at least two weeks in advance of the planned submission. See Section IV.

Two steps are required for on time submission:

1) The application must be submitted to Grants.gov by the submission date (see “Key Dates” below)

2) Applicants must complete a verification step in the eRA Commons within two business days of notification from NIH. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the Commons.

The purpose of the Academic Research Enhancement Award (AREA) program is to stimulate research in educational institutions that provide baccalaureate or advanced degrees for a significant number of the Nation's research scientists, but that have not been major recipients of NIH support. These AREA grants create opportunities for scientists and institutions otherwise unlikely to participate extensively in NIH programs, to contribute to the Nation's biomedical and behavioral research effort.

AREA grants are intended to support small-scale health-related research projects proposed by faculty members of eligible, domestic institutions.

The total amount awarded and the number of awards will depend upon the quality, duration, and costs of the applications received.

This funding opportunity will use the R15 mechanism.

Eligible organizations include all public or private institutions and components of institutions such as health professional schools/colleges and other academic components of domestic institutions offering baccalaureate or advanced degrees in the sciences related to health, except those that have received research grants and/or cooperative agreements from the NIH totaling more than $3 million per year (in both direct and indirect costs) in each of four (4) or more of the last seven (7) years.

Eligible Project Director/Principal Investigators (PD/PIs) include individuals with the skills, knowledge, and resources necessary to carry out the proposed research. Applicants may not be the PD/PI of any active NIH research grant, including another AREA grant, at the time of award of an AREA grant.

Applicants may request up to $150,000 direct costs plus applicable Facilities & Administrative (F&A)/indirect costs for the entire project period of up to three (3) years. Note when a consortium is involved, the $150,000 direct cost limit is exclusive of consortium F&A costs. These can be requested in addition to the $150,000 direct costs limit.

Applicants may submit more than one application, provided they are scientifically distinct, but an applicant may have only one AREA grant at a time.

The National Institutes of Health (NIH) is continuing to make a special effort to stimulate research in educational institutions that provide baccalaureate or advanced degrees for a significant number of the Nation's research scientists, but that have not been major recipients of NIH support. Since Fiscal Year (FY) 1985, Congressional appropriations for the NIH have included funds for this initiative, which NIH has implemented through the Academic Research Enhancement Award (AREA) program. Based on the expectation that funds will continue to be available each year, the NIH invites applications for AREA grants (R15) through a standing, ongoing Funding Opportunity Announcement (FOA).

AREA funds are intended to support new ("type 1") and renewal ("type 2") biomedical and behavioral research projects proposed by faculty members of eligible colleges, universities, schools, and components of domestic institutions. The AREA program will enable qualified scientists to receive support for small-scale research projects. These grants are intended to create a research opportunity for scientists and institutions otherwise unlikely to participate extensively in NIH programs to support the Nation's biomedical and behavioral research effort. It is anticipated that investigators supported under the AREA program will benefit from the opportunity to conduct independent research; that the grantee institution will benefit from a research environment strengthened through AREA grants and furthered by participation in the diverse extramural programs of the NIH; and that available students will benefit from exposure to and participation in research in the biomedical and behavioral sciences.

The AREA program is a research grant program and not a training or fellowship program. Active involvement of undergraduate and graduate students in the proposed research is encouraged, and reviewers will consider whether the proposed project will expose undergraduate (preferably, if available) and graduate students to meritorious research. However, the application should not focus on training objectives and training plans should not be provided.

Research Objectives of the NIH Institutes and Centers

At institutions that have not been major recipients of NIH support, AREA grants may support small-scale, new or renewal, meritorious projects in biomedical and behavioral research, including:

pilot research projects and feasibility studies

development, testing, and refinement of research techniques

secondary analysis of available data sets

similar discrete research projects that demonstrate research capability

The AREA program Web site (http://grants.nih.gov/grants/funding/area.htm) lists the AREA program representative for each of the participating Institutes and Centers (ICs). For additional scientific program information and for pre-application guidance, a potential applicant is encouraged to contact the person listed for the particular NIH IC(s) with research interests relevant to the applicant's proposed topic. Also listed on the AREA program Web site are the research objectives of the NIH ICs and their Web sites.

This funding opportunity will use the R15 mechanism for the Academic Research Enhancement Award (AREA) program.

This funding opportunity uses just-in-time concepts. It also uses the modular budget formats. Use the PHS 398 Modular Budget component attached to this announcement in Grants.gov/Apply. See specifically the PHS 398 Modular Budget, Period 1.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

For Project Directors/Principal Investigators (PD/PIs) who receive AREA funding, there are additional opportunities for administrative supplements to improve the diversity of the research workforce by supporting and recruiting high school and undergraduate students from groups that have been shown to be underrepresented (see PA-05-015, http://grants.nih.gov/grants/guide/pa-files/PA-05-015.html).

2. Funds Available

Applications received in response to this funding opportunity announcement (FOA) will compete for funds with other AREA applications to the participating NIH ICs. The number and size of the awards will depend on the number of applications submitted, their relative scientific merit, and the general availability of funds for investigator-initiated research at the participating ICs. Information on past awards is available at the AREA program Web site: http://grants.nih.gov/grants/funding/area.htm.

Applicants may request a maximum of $150,000 total direct costs plus applicable Facilities & Administrative (F&A)/indirect costs for the entire project period of up to three years. Note when a consortium is involved, the $150,000 direct cost limit is exclusive of consortium F&A costs. These can be requested in addition to the $150,000 direct costs limit.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your domestic organization has any of the following characteristics:

Public or private institutions and components of institutions defined below as “health professional schools/colleges” and “other academic components.”

Applicant Schools/Components:

The applicant organization must offer baccalaureate or advanced degrees in the sciences related to biomedical and behavioral and meet the requirement of receiving research grants and/or cooperative agreements from the NIH totaling not more than $3 million per year (in both direct and F&A/indirect costs) in each of four (4) or more of the last seven (7) years. Note that this criterion of financial eligibility is based on the amount of NIH research grant monies received, not by the institution (university or college) as a whole, but by the individual school/college or aggregation of "other academic components" (see definition below) where the PD/PI has an appointment (e.g., School of Medicine, College of Nursing, etc.). To determine the eligibility of a school or component with regard to this requirement, applicants should consult the list of ineligible schools/components on the AREA program Web site at http://grants.nih.gov/grants/funding/area.htm. If the name of the school does not appear on the list, it may be eligible to apply for AREA grants. Applicants should check with their own institutions if unsure.

For purposes of eligibility for the AREA program, the following definitions apply:

"Health professional schools/colleges that are components of universities/colleges" (include schools or colleges of medicine, dentistry, osteopathy, pharmacy, nursing, veterinary medicine, public health, optometry, allied health, chiropractic, naturopathy and podiatry) means an accredited public or non-profit private school that provides training leading to a degree related to the health sciences granted by that school (e.g., M.D., D.D.S., M.P.T., D.C., N.D. or equivalent degree). The term "accredited" means a school or program that is accredited by a recognized body or bodies approved for such purpose by the Secretary of Education.

"Other academic components" applies to institutions which include one or more health professional schools. Once the health professional schools have been excluded, “other academic components” refers to all remaining schools, colleges, and free-standing institutes of the institution taken as a SINGLE component.

An applicant school/component may submit several applications proposing different research projects from different investigators. Although foreign institutions are not eligible, applications may include a foreign collaboration, component, or consortium.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.Scientists working in AREA-eligible minority or women's educational institutions are also encouraged to participate in this program.

However, applicants:

May not be the Project Director/Principal Investigator (PD/PI) of any active NIH research grant at the time of award of an AREA grant (although he or she may be one of the project personnel for an active NIH grant held by another PD/PI).

May not be awarded more than one AREA grant at a time (although he or she may hold successive new or competing renewal AREA grants).

May not submit an application to NIH for another research grant for essentially the same project proposed in a pending AREA application (in accordance with the general NIH prohibition against the submission in the same review cycle of more than one application for the same work).

2. Cost Sharing or MatchingNot required.

3. Other-Special Eligibility Criteria Not applicable.

Section IV. Application and Submission Information

Registration and Instructions for Submission via Grants.gov

To download an Application Package and Instructions for completing the SF424 Research and Related (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that site.

Several of the steps of the registration process could take up to two weeks. Therefore, applicants should immediately check with their institution official to determine whether their institution is already registered in both Grants.gov and the Commons.

Please direct questions regarding the Commons registration process to the NIH eRA Commons Help Desk at phone: 301-402-7469 or 866-504-9552 (Toll Free) or 301-451-5939 (TTY) during business hours on M-F from 7AM-8PM, Eastern Time.

1. Address to Request Application Information

Applicants must download the SF424 (R&R) application forms and instructions for this FOA through the Grants.gov/Apply http://www.grants.gov/Apply Web site.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

Prepare all AREA applications using the SF424 (R&R) application forms and SF424 (R&R) Application Guide (MS Word or PDF) instructions.

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this announcement in Grants.gov APPLY will include all applicable components, required and optional. A completed application in response to this announcement will include the following components:

3.A.2. Letter of IntentA letter of intent is not required for the funding opportunity.

3.B. Sending an Application to the NIH

To submit an application in response to this FOA, applicants should access this FOA viahttp://www.grants.gov/ Apply and follow the application guide for the SF424 (R&R) forms.

Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

Applications may be submitted to Grants.gov on or after January 17, 2006 (i.e., the Open Date on Grants.gov) and must be submitted no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission date described above (Section IV.3.A.). If an application is not submitted by that date, the application may be delayed in the review process or not reviewed.

Note that the “open” and “close” dates in Grants.Gov are not the same as the submission and receipt dates described below. The “open” and “close” dates span the life of the funding opportunity. Applicants are reminded to follow the submission dates cited in this FOA.

Upon receipt, applications will be transferred from Grants.gov to the NIH Electronic Research Administration process for validation. Both the PD/PI and the Signing Official for the organization must verify the submission via Commons within 2 business days of notification of the NIH validation.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review (CSR), NIH. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.Subsequent information about review outcome, summary statement, and status of the application should be accessed by the applicant PD/PI in the Commons.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing renewal (formerly, “competing continuation”) award if such costs are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement.

Allowable direct costs include salaries for the PD/PI and other research personnel (including students), supplies, equipment, travel, and other items specifically associated with the proposed research project.

6. Other Submission Requirements

TYPE OF APPLICATION. Item 8 of first page of SF424 (R&R): Check “New” if this is the first submission. Check “Renewal” if this is a competing submission of an ongoing project. Check “Resubmission” if this is the second or third submission of a new or renewal application. The Continuation and Revision categories are not normally applicable to AREA or R15 applications.

PROPOSED PROJECT. Item 13: The entire proposed project period may be one, two, or three years, but may not exceed three years. Enter the proposed start and end dates of the proposed project.

ESTIMATED PROJECT FUNDING. Items 16: Enter the Total Costs or the sum of Direct Costs (in $25,000 increments up to a maximum of $150,000) plus Facilities & Administrative (F&A)/Indirect Costs for the entire project period.

FACILITIES & OTHER RESOURCES. Line 9 on the Research & Related Other Project Information form component requires a PDF attachment. In addition to the information requested in the instructions, provide the following information:

A profile of available students of the applicant school/academic component and any information or estimate of the number who have obtained the baccalaureate degree and gone on to obtain an academic or professional doctoral degree in the health-related sciences during the last five years.

A description of the special characteristics of the school/academic component that make it appropriate for an AREA grant, where the goals of the AREA program are to: (1) provide support for meritorious research; (2) strengthen the research environment of schools that have not been major recipients of NIH support; and (3) expose available undergraduate and/or graduate students in such environments to research. Include a description of the likely impact of an AREA grant on the PD/PI and the research environment of the school/academic component.

Although it is expected that the majority of the research will be directed by the applicant investigator and conducted at the grantee institution, limited use of special facilities or equipment at another institution is permitted. For any proposed research sites other than the applicant institution, provide a brief description of the resources. Collaborations with other investigators are also permitted if complementary expertise is required to accomplish the proposed specific aims.

If relevant, a statement of institutional support for the proposed research project (e.g., special equipment or space, release time, other support, matching funds, etc.).

RESEARCH AND RELATED SENIOR/KEY PERSON - BIOGRAPHICAL SKETCH. The Biographical Sketch provides information used by reviewers in the assessment of each individual's qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, including collaborators, following the instructions below. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/424/index.htm. Attach the Biographical Sketches to the Research and Related Senior/Key Person page.

List education and training; selected peer-reviewed publications, with full citations; position(s); any honors, and any grant support, with information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years.

For the PD/PI only, provide information on his or her (a) previous or current experience in supervising students in research, and/or (b) other relationships within the institutional framework (e.g., cross-departmental research collaborations.

RESEARCH AND RELATED SENIOR/KEY PERSON - CURRENT & PENDING SUPPORT. Do not attach this information at the time of application. This information is no longer required at the time of application submission. This information may be requested later in the pre-award process. However, the Biographical Sketch for each key personnel should include information on the other projects that the person is working on or has worked on that are relevant to the proposed project (see above).

PHS 398 MODULAR BUDGET COMPONENT, PERIOD 1 - This funding opportunity uses the modular budget format. In this component, complete only Budget Period 1. Include in budget period 1 the total requested budget for all years of the proposed project.

Budget Period 1: Direct Costs

Direct Costs less Consortium F&A: Select the appropriate dollar amount from the drop-down list. This number may NOT EXCEED $150,000.

BUDGET JUSTIFICATIONS – Please attach the justification for personnel and the justification for any consortium, if applicable. If the requested budget requires any additional justification, attach an Additional Narrative Justification.

If students are available and will be involved in the research, indicate in what aspects of the proposed research they will participate. If participating students have not yet been individually identified, the number and academic level of those to be involved should be provided. Since a primary objective of the AREA program is to support investigators doing meritorious research at institutions that have not been major recipients of NIH support, PD/PIs are encouraged to include undergraduate (preferably, if available) and graduate students in the proposed research to the extent practicable. If there are any Consultants for the project, provide their names, organizational affiliations, and the services they will perform.

For the Consortium Justification, provide an estimate of total costs (direct cost plus F&A cost), each rounded to the nearest $1,000. List the individuals and their organizations with which consortium arrangements have been made, the percent effort of all personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. Include the Letter of Intent to establish a consortium.

Section V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications submitted for this funding opportunity announcement (FOA) will be assigned to the NIH Institutes and Centers (ICs) on the basis of established PHS referral guidelines.

Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.

Receive a written critique.

Receive a second level of review by the appropriate national advisory council or board.

The following will be considered in making funding decisions:

Scientific merit of the proposed project as determined by peer review.

Availability of funds.

Relevance of program priorities.

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Overall Evaluation: Summarize the major factors from the five review criteria above that contribute to or detract from scientific merit. In addition, evaluate whether the proposed project addresses the objectives of the AREA grant program which are to (1) provide support for meritorious research, (2) strengthen the research environment of schools that have not been major recipients of NIH support, and (3) expose available undergraduate and graduate students in such environments to meritorious research.

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed [see the Research Plan, item 6 of the SF424 (R&R) form].

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated [see the Research Plan, item 7 of the SF424 (R&R) form].

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan in the SF424 (R&R) form will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

3. Anticipated Announcement and Award DatesNot applicable.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will have access to a written critique called a Summary Statement. This document will only be accessible electronically in the NIH eRA Commons. NIH will no longer send hard copies of the Review Outcome or Summary Statements to applicants (see NOT-OD-05-075 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-075.html).

If the application is under consideration for possible funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5. Funding Restrictions.

By or on the anniversary date of the AREA grant, awardees should submit a progress report electronically to the Program Director or Program Officer for the R15 at the funding NIH Institute or Center. There are no form pages, but the report should include the relevant grant information, the proposed specific aims, any progress on those aims, any manuscripts or publications, and the list of personnel involved in the research project.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Questions regarding eligibility, policies, procedures, and other administrative aspects of the NIH AREA program should be referred first to the Office of Sponsored Programs at the educational institution. Program Guidelines and other information related to the AREA program are available on the AREA Web page at: http://grants.nih.gov/grants/funding/area.htm

Human Subjects Protection:Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Access to Research Data through the Freedom of Information Act:The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statementhttp://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). Beginning with the October 1, 2004 receipt date, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new SF424 (R&R); and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

Standards for Privacy of Individually Identifiable Health Information:The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR Website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.